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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector

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  Class 2 Device Recall Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector see related information
Date Initiated by Firm March 12, 2013
Date Posted November 27, 2013
Recall Status1 Terminated 3 on June 26, 2014
Recall Number Z-0426-2014
Recall Event ID 65985
510(K)Number K983017  K122172  
Product Classification Endoscope and/or accessories - Product Code KOG
Product Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Code Information Multiple serial numbers
Recalling Firm/
Manufacturer		 Custom Ultrasonics, Inc.
144 Railroad Dr
Ivyland PA 18974-1449
For Additional Information Contact Customer Support
215-364-1477
Manufacturer Reason
for Recall		 Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.
FDA Determined
Cause 2		 Software design
Action A notification letter, dated February 26, 2013, was sent to direct accounts to inform them of the recall and that technicians would visit facilities to replace the Windows 7 operating system with an appropriately validated Windows XP operating system.
Quantity in Commerce 118
Distribution Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KOG and Original Applicant = CUSTOM ULTRASONICS
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